Optimized Multichannel tDCS Protocol vs Conventional and Sham tDCS for Clinical Use in Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale scores
研究概览
简要总结
In this project, the efficacy of different tDCS protocols in major depression will be investigated. The tDCS protocols have already been investigated in humans, and results showed that stimulation intensity has a different effect on tDCS long-term aftereffects based on the human motor cortex model. The project has three major goals: first, we want to see if the differential outcome of tDCS dosage, as present in healthy populations, can be translated to patients with major depression. Second, we want to compare the efficacy of a multi-channel novel protocol with conventional tDCS modules. Lastly, we are interested in the safety and tolerability of optimized multi-channel. The project output will be an optimized tDCS protocol for major depression treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
to secure investigator blinding, interventions were applied by independent investigators who were not involved in outcome measure ratings
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-5 criteria for a moderate-to-severe major depression, primarily by a DSM-5-based structured interview by a licensed psychiatrist, confirmed by score on Hamilton Rating Scale for Depression (HAMD)
- •being 18-60 years old
- •providing written informed consent
- •If female, negative urine pregnancy test
- •Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclics (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention
排除标准
- •pregnancy
- •alcohol or substance dependence
- •history of seizure
- •history of neurological disorder
- •comorbid Schizophrenia Axis I disorder, bipolar disorder, substance abuse or dependence, dementia, personality disorder
- •history of head injury
- •currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
- •Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)
研究组 & 干预措施
conventional tDCS group
The conventional tDCS group will receive 30 sessions of 20-minute stimulation at 2 mA intensities using standard electrodes (7 x 5 cm) over the target region
干预措施: transcranial direct current stimulation (tDCS) (Device)
multi-channel tDCS group
The multi-channel tDCS group will receive 30 sessions of 20-minute stimulation at 2 mA intensities using 7 electrodes (11 mm) over the target region
干预措施: multichannel transcranial direct current stimulation (tDCS) (Device)
sham tDCS group
The conventional tDCS group will receive 30 session of 20-minute placebo stimulation using standard electrodes (7 x 5 cm) over the target region
干预措施: transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale scores
时间窗: up to 3 months after the intervention
the score on the MADRS (Montgomery-Asberg Depression Rating Scale)
Hamilton Depression Rating Scale scores
时间窗: up to 3 months after the intervention
the score on the Hamilton Depression Rating Scale (HDRS). The HDRS is a multiple-item questionnaire designed for measuring adult depression and is administered by health care professionals. It is currently the most common depression measure used worldwide. Items on the HDRS are scored from 0 to 4 or 0 to 2 depending on the symptom assessed, with high scores indicating greater symptom pathology. scores typically ranging from 15 to 20 indicate a clinical level of depressive symptomatology
Beck Depression Inventory scores
时间窗: up to 3 months after the intervention
the score on the Beck Depression Inventory (BDI-II). The BDI is a self-reported twenty-one questions about how the subject has been feeling in the last week, and each question has four answers ranging in intensity. Scoring 19 or higher on the BDI-II is considered moderate depression
次要结局
- Working memory task(up to 1 month after the intervention)
- Attention task(up to 1 month after the intervention)
- electroencephalogram (EEG) functional connectivity(up to 1 week after the intervention)
- Emotion Recognition Task(up to 1 month after the intervention)
- electroencephalogram (EEG) power(up to 1 week after the intervention)
研究者
Mohammad Ali Salehinejad
Principal Investigator
RWTH Aachen University